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A Preliminary Report of Phase I and II Study of N4-Behenoyl-1-{beta}-D-arabinofuranosylcytosine (BH-AC) in Patients with Acute Leukemia and Other Malignancies |
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| Authors: | TANIMOTO, MITSUNE OHNO, RYUZO KATO, YUKIO TAKAMATSU, JUNKI WATANABE, EIJI SUZUKI, HISAMITSU MORISHTMA, YASUO TAKEYAMA, HTDEO KOBAYASHI, MASAHIDE OGATA, KANJI KODERA, YOSHTHISA EZAKI, KOHJI KAWASHTMA, KOHET KAMTYA, TADASHT MINAMI, SABURO YOSHTKAWA, HARUYA NISHIWAKI, HIROSHI YOSHIKAWA, SATOSHI YAMADA, KAZUMASA |
| Affiliation: | 1First Department of Internal Medicine, Nagoya University, School of Medicine Nagoya, Japan 2Aichiken Shokuin Hospital Nagoya, Japan 3Hamamatsu Medical Center Hamamatsu 4Daido Hospital Nagoya, Japan 5Nagoya First Red Cross Hospital Nagoya, Japan |
| Abstract: | N4-Behenoy1-1-ß-D-arabinofuranosy1cytosine (BH-AC)was administered to 11 patients with acute leukemia and fivepatients with other malignancies in a Phase I and TI clinicaltrial. Among 16 patients, 14 received BH-AC after being refractoryto prior therapies, and two with acute leukemia received BH-ACfor their first remission induction therapy. The starting dose was 1.5mg/kg administered as a single i.v.infusion of three hours. The doses were then escalated up to5.0 mg/kg. No side effects were noted with single i.v. infusions.Daily consecutive infusions of 2.0 mg to 6.0 mg/kg for fourto 21 days resulted in two patients experiencing nausea, twoanorexia and one developing skin eruptions. Significant hematologicaleffects were noted by the daily infusions. One patient withacute myeloblastic leukemia achieved complete remission with5.0 mg/kg BH-AC administered daily for 21 days. BH-AC is active in acute leukemia and may play a role in thecombination regimens for this disease. |
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